International Study to Predict Optimised Treatment - in Depression (iSPOT-D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00693849
Recruitment Status : Active, not recruiting
First Posted : June 9, 2008
Last Update Posted : July 11, 2018
Information provided by (Responsible Party):
BRC Operations Pty. Ltd.

June 6, 2008
June 9, 2008
July 11, 2018
September 2008
December 2019   (Final data collection date for primary outcome measure)
To determine whether the genetic-brain-cognition function markers (or combination of markers) 'normalise' with acute drug treatment in MDD [ Time Frame: Week 8 ]
Same as current
Complete list of historical versions of study NCT00693849 on Archive Site
To determine whether markers of acute treatment prediction are also predictive of functional outcome over 6-12 months. [ Time Frame: 52-weeks ]
Same as current
Not Provided
Not Provided
International Study to Predict Optimised Treatment - in Depression
International Study to Predict Optimised Treatment - in Depression
The aim of this study is to identify genetic, physical (brain) and psychological (cognitive) markers (or combinations of them) that predict specific response to a range of antidepressants treatment (Escitalopram, Venlafaxine, Sertraline) in patients diagnosed with major depressive disorder. This study is focused on outcomes which may impact on how "personalised medicine" is implemented in depression.

This is an open-label, randomised (effectiveness) study (ie. comparison of active treatments) to identify genetic markers, brain function, brain structure, and psychological and cognitive indicators (or a combination of markers) in MDD subjects versus healthy controls. Approximately 2,016 subjects with major depressive disorder (MDD) across multiple international sites (USA, Canada, UK, South Africa, New Zealand, The Netherlands and Australia) will be randomised to one of three approved and effective treatment arms:

Treatment A Escitalopram. Treatment B Sertraline. Treatment C Venlafaxine XR.

A group of matched healthy controls (n = 672) will also be enrolled.

Subjects will be asked to attend the testing facility on two separate occasions; for Pre-treatment (Pre-Tx) and at 8 weeks post initiation of treatment. The assessments/procedures at Pre-Tx and Week 8 include: Baseline a clinical work-up, blood collection for genetic analyses, cognitive testing and electrical brain functioning (EEG/ERP). Structural and functional data MRI data will be collected in ten percent (10%) of participants.

On Day 4 and Weeks 2, 4, 6, 12, 16, 24 and 52 Subjects will be contacted by phone and asked to complete 2 questionnaires via the internet.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Major Depressive Disorder
  • Drug: Escitalopram
    10 mg/day as a single dose, increased to max 20 mg/day
    Other Name: Lexapro
  • Drug: Sertraline
    50 mg/day as a single dose, increased to max of 200 mg/day
    Other Name: Zoloft
  • Drug: Venlafaxine-XR
    75 mg/day given once daily; increased to 150-225 mg/day
    Other Name: Effexor
  • Active Comparator: A
    Intervention: Drug: Escitalopram
  • Active Comparator: B
    Intervention: Drug: Sertraline
  • Active Comparator: C
    Intervention: Drug: Venlafaxine-XR
  • No Intervention: D
    Healthy matched controls

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meet DSM-IV criteria for primary diagnosis of MDD.
  • HAM-D17 score of ≥ 16.
  • 18-65 years age-range
  • Subjects with English or Dutch literacy and fluency.
  • Written, informed consent.

Exclusion Criteria:

  • Presence of suicidal ideations and/or tendencies (as determined by a score >12 on Section C, Suicidality, of the MINI Plus), Bipolar I-III, psychosis, primary eating disorders, Post Traumatic Stress Disorder (PTSD), Obsessive Compulsive Disorder (OCD), Post-Natal Depression as well as any Axis II personality disorders as diagnosed using the MINI Plus or by a health care professional.
  • Pregnancy and women of child bearing potential who are not taking a medically accepted form of contraception and are at risk of becoming pregnant during the study.
  • Breastfeeding.
  • Known contra-indication or intolerance to the use of Escitalopram, Sertraline or Venlafaxine XR as defined in the product package insert for each drug (including previous treatment failure at the highest recommended dose).
  • Use of any psychological or counselling therapy or antidepressant/CNS drug which cannot be washed out prior to participation and eliminated until after Week 8 or discontinuation.
  • Use of any medication which is known to be contraindicated with Escitalopram, Sertraline, or Venlafaxine XR (refer to the product package insert for each drug).
  • Known medical condition, disease or neurological disorder which might, in the opinion of investigator/s, interfere with the assessments to be made in the study or put subjects at increased risk when exposed to optimal doses of the drug treatment.
  • History of head injury with loss of consciousness for at least 10 minutes.
  • Recent/current substance dependence (as defined in Section K of the Mini Plus as per a 6 months period and/or alcoholism) in the past six months.
  • Participation in an investigational study within four months of the baseline visit in which subjects have received an experimental drug/device that could affect the primary end points of this study.
  • Subjects who, in the opinion of the investigator, have a severe impediment to vision, hearing and/or hand movement, which is likely to interfere with their ability to complete the test batteries.
  • Subjects who, in the opinion of the investigator, are unable and/or unlikely to comprehend and follow the study procedures and instructions.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Australia,   Netherlands,   New Zealand,   South Africa,   United States
Not Provided
Not Provided
BRC Operations Pty. Ltd.
BRC Operations Pty. Ltd.
Not Provided
Principal Investigator: Anthony Harris, MD Brain Dynamics Centre
Principal Investigator: Barbara A. Cohen, PhD Center for Healing the Human Spirit
Principal Investigator: Bruce Russell, PhD University of Auckland, New Zealand
Principal Investigator: Charles Debattista, MD Stanford University
Principal Investigator: Con Stough, PhD Swinburne University
Principal Investigator: Elizabeth Wallis, PhD Brain Health Lab
Principal Investigator: Harbans Multani, MD Shanti Clinical Trials
Principal Investigator: Jayashri Kulkarni, Prof The Alfred and Delmont Private Hospital
Principal Investigator: Jeffrey Wilson, PhD A.D.D. Treatment Center
Principal Investigator: Kamran Fallahpour, PhD Brain Resource Center
Principal Investigator: Larry Hirshberg, PhD NeuroDevelopment Center
Principal Investigator: Martijn Arns, PhD Brainclinics Diagnostics B.V.
Principal Investigator: Mona Ismail, MD Brain Resource Center
Principal Investigator: Paul Fitzgerald, PhD The Alfred
Principal Investigator: Richard Clark, PhD Flinders University
Principal Investigator: Roger deBeus, PhD Skyland Behavioral Health Associates
Principal Investigator: Steven Bruce, PhD University of Missouri, St. Louis
Principal Investigator: Subhdeep Virk, MD Ohio State University
Principal Investigator: Tim Usherwood, MD Brain Dynamics Centre
Principal Investigator: XiaoLei Yu Baran, MD Cornell University
Principal Investigator: Radu V Saveanu, MD University of Miami
BRC Operations Pty. Ltd.
July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP